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Recall Observatory FDA recall evidence

Device product

JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240

Z-0765-2022

December 22, 2021

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 89468
Status
Ongoing
Classification
Class II
Quantity
7115 units
Official record key
device-enforcement:Z-0765-2022

Official wording

Reason: Sterility of device is compromised due to a sterile barrier breach

Code information: Lot Numbers: 27481920 27524107 27525279 27530542 27574053 27598798 27652479 27722062 27722511 27742261 27758891 27795634 27846706 27897451 27969768 28027118 28070708 GTIN: 8714729953234

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    compromised due to a sterile barrier